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A Trial of One-week on/One-week Off Temozolomide Versus Continuous Dose-Intense Temozolomide in Patients With Glioblastoma Multiforme at First Relapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02330991
Recruitment Status : Active, not recruiting
First Posted : January 5, 2015
Last Update Posted : February 12, 2020
Information provided by (Responsible Party):
Junping Zhang, Beijing Sanbo Brain Hospital

Brief Summary:
The purpose of this study is to evaluate the clinical benefit and safety of two different Dose-Intense temozolomide regimens(one-week on/one-week off regimen versus continuous dose-intense regimen)in patients with glioblastoma at first relapse.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Temozolomide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : January 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm1 ,one-week on/one-week off regimen
One-week on/one-week off regimen is administered for 12 cycles of 28 days. Arm 1 receives temozolomide 150 mg/m2 daily during days 1 to 7 and 15 to 21 of each cycle.Treatment will continue until tumor progression, development of excessive toxicity, withdrawal of consent, or completion of 12 cycles.
Drug: Temozolomide
Other Name: Temodal

Experimental: Arm 2,continuous dose-intense regimen
Continuous dose-intense regimen is administered for 12 cycles of 28 days .Arm 2 receives temozolomide 50mg/m2 daily during days 1 to 28 of each cycle. Treatment will continue until tumor progression, development of excessive toxicity, withdrawal of consent, or completion of 12 cycles.
Drug: Temozolomide
Other Name: Temodal

Primary Outcome Measures :
  1. Progress-Free Survival at 6 months (PFS6) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Overall Survival(OS) [ Time Frame: 2 years ]
  2. Progression free survival [ Time Frame: 2 years ]
  3. Objective Response Rate [ Time Frame: up to 52 weeks ]
  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: up to 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Participants must have histopathologically-confirmed, supratentorial, glioblastoma.
  2. Participants must have received first-line treatment regimen consisting of RT plus concomitant temozolomide followed by adjuvant temozolomide.
  3. Participants must be first recurrence or progression of glioblastoma after first-line treatment regimen.
  4. Participants must have demonstration of recurrent disease on MRI following prior therapy.
  5. Participants must have bi-dimensionally measurable disease with a minimum measurement of 1 cm in one dimension on MRI performed within 14 days prior to first treatment. If receiving corticosteroids, participants must be on a stable or decreasing dose of corticosteroids for at least 5 days prior to baseline MRI.
  6. Participants must have developed progressive disease after receiving prior therapy and must have an interval of at least 12 weeks from the completion of radiation and concomitant temozolomide therapy to study entry (unless progressive tumor growth is outside the radiation field or there is histopathological confirmation of recurrent tumor)
  7. Age 18-75 years old.
  8. Life expectancy of at least 12 weeks.
  9. Karnofsky performance status at least 60
  10. Participants must be able to adhere to the dosing and visit schedules, and agree to record medication times, concomitant medications, and adverse events (AEs) accurately and consistently in a daily diary.
  11. 20 paraffinsections of glioblastoma tissue must be available.
  12. Participants must have normal organ and marrow function as defined below: leukocytes >4.0×10^9/L,platelets >100×10^9/L,Hemoglobin > 10 g/dl,Serum creatinine< 1.5-fold upper normal range,AST and ALT <2-fold upper normal range, Alkaline phosphatase < 3-fold upper normal range.
  13. Female and male subjects of childbearing potential must agree to use a medically accepted method of adequate contraception.

Exclusion Criteria:

  1. Treatment with any chemotherapy other than temozolomide prior to enrollment.
  2. Progressive or recurrent glioblastoma documented by MRI earlier than 12 weeks after completion of radiotherapy.
  3. History of any other cancer.
  4. HIV infection.
  5. Women who are pregnant or breast feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02330991

Sponsors and Collaborators
Beijing Sanbo Brain Hospital
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Principal Investigator: Junping Zhang, MD Beijing Sanbo Brain Hospital
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Responsible Party: Junping Zhang, Chief Physician, Beijing Sanbo Brain Hospital Identifier: NCT02330991    
Other Study ID Numbers: 2014062501
First Posted: January 5, 2015    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Keywords provided by Junping Zhang, Beijing Sanbo Brain Hospital:
glioblastoma at first relapse
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents